Protocol Specific Research (PSR) provides support for development and conduct of short term pilot and early phase investigator-initiated clinical trials. PSR support is allocated for protocol development. Scientific Review Committee and IRB submission, data management, nursing support, and regulatory support. In addition, PSR support provides assurance that relevant investigator-initiated trials selected for funding have a full Data and Safety Monitoring Plan (DSMP), and that each trial receives internal quality assurance reviews. PSR services are available to all members of the Cancer Center. The first priority for utilization of PSR support services is given to investigator-initiated studies and NCI-sponsored trials.